ADVANCING MEASUREMENT OF PATIENT-CENTERED COMMUNICATION IN CANCER CARE Support a project that will lead to the development and cognitive testing of self-reported measures for assessing patient-centered communication (PCC) processes in cancer care delivery in a variety of treatment settings. This project will build upon existing collaborations between NCI and AHRQ in this area of research. The Institute of Medicine (IOM) has identified [unreadable]patient-centeredness[unreadable] as one of six key aims to be accomplished by the health care system of the 21st century. While several definitions and conceptualizations of patient-centered care exist in the literature, two key attributes are common: the health care system should: 1) deliver care that is responsive to and supportive of key patient needs, and 2) incorporate patient perspectives in making and implementing critical medical decisions. In the case of cancer and other chronic illnesses that are characterized by long-term interactions between patients and clinicians, patient-centeredness is more likely to be achieved when support provided by the health care system to patients is ongoing and delivered within the context of continuous healing relationships as opposed to a single transaction. Communication between members of the health care delivery system and patients is the primary vehicle for delivering such supportive, [unreadable]patient-centered[unreadable] care. The Division of Cancer Control and Population Sciences (DCCPS) of the National Cancer Institute (NCI) has identified the measurement, monitoring, and improvement of patient-centered care across the cancer continuum as a key research priority. In 2007, NCI published a monograph authored by Epstein &Street that identified six key functions of patient-centered communication: fostering healing relationships, exchanging information, making medical decisions, responding to patient emotions, managing uncertainty, and enabling patient self-management. In the same year, DCCPS also collaborated with AHRQ on a research project that would lay the groundwork for measurement of patient-centered communication in cancer care. Funded as part of AHRQ[unreadable]s DEcIDE research network to RTI International, the focus of this project was to identify measurable domains and sub-domains of the six functions of patient-centered communication identified in the NCI monograph. While this collaboration between NCI and AHRQ has resulted in a comprehensive inventory of domains and sub-domains of PCC, several challenges to measurement were also identified including significant overlap in concepts and operationalization among several of the six PCC functions. The project proposed in the current IAA will draw upon the lessons learned from RTI International[unreadable]s DEcIDE network project and will develop and cognitively test measures of patient-centered communication in cancer care. This follow-up project would be conducted via a contract mechanism to be awarded by AHRQ in consultation with NCI, to one or more private-sector groups that participate in AHRQ[unreadable]s DEcIDE research network. The project will focus on developing self-reported measures for the diagnosis (starting from suspicion of cancer) through end of treatment phase of the cancer control continuum. The phases of primary prevention, screening, post-treatment survivorship, and end-of-life care will not be covered. The primary focus of the project would be to develop and test measures of patients[unreadable] care experiences to be used for organizational level surveillance to monitor cancer care quality in multiple health care delivery settings. Secondary foci of the project include identification of a subset of items that could used for assessment of the perspective of healthcare professionals for organizational surveillance and development of a patient survey that could be used for population-level surveillance efforts such as national or regional surveys. The contractor will accomplish the following four major objectives: a. Refine measurement model i. Based on the work done by RTI International in the prior DEcIDE project, refine the measurement model for patient-centered communication that would address the challenges identified related to conceptual and empirical overlap among several of the six functions of PCC. ii. Get key stakeholder and scientific feedback on the updated measurement model and make requisite modifications. b. Develop measures i. Create an inventory of existing measures for the key constructs of PCC identified in the measurement model. ii. Create candidate items to measure areas of the key constructs for which gaps exist in the current available measures. c. Test measures i. Conduct cognitive testing of the measures in a wide variety of patient groups to refine and/or eliminate items as necessary. d. Finalize surveys i. Format final surveys for organizational and population level surveillance that would include the final battery of items measuring the key constructs of PCC based upon cognitive testing and scientific input from key experts. ii. Develop items, based on refinements to relevant items from the patient survey, for use in a brief organizational-level survey on the perspectives of health care providers related to PCC. AHRQ and NCI would work collaboratively to select one or more potential contractors from within the membership of AHRQ[unreadable]s DEcIDE network. While the contract would be administered by AHRQ, the NCI project officer will, along with the AHRQ Task Order Officer (TOO), serve as co-scientific lead for the federal government. The four major objectives identified above will be accomplished by the contractor by conducting the following core tasks in consultation with scientific staff from AHRQ and NCI: 1. Establish a scientific evaluation group (SEG) to provide input on work for the project. The contractor shall identify relevant scientific and clinical experts to provide feedback on work performed in the task order. The group shall serve as consultants to the contractor to provide input to their work. The contractor shall submit a list of candidates to AHRQ and NCI for approval. While the areas of expertise represented are negotiable, it is recommended that the SEG include at least one communication scientist, an oncologist, an oncology nurse, a patient advocate, a quality of care expert, and a survey methodologist. The AHRQ TOO and NCI project officer shall also serve as members of the SEG. 2. Refine the measurement model of PCC. To overcome the problem of overlap among the six functions of PCC, the contractor shall propose to AHRQ and NCI refinements to the six function model that drove the earlier work conducted by RTI International. One potential refinement being contemplated by NCI and AHRQ that the contractor may further improve upon is based upon the literature on social support, coping, and self-regulation of illness. The social support literature identifies three important areas where chronically ill patients are likely to need support from the health care system: emotional support, cognitive support, and instrumental support. Based on existing literature on coping theory and the self-regulation model of illness, three corresponding functions of PCC that address each of the three areas of support needs of patients can be identified: facilitation of emotional adjustment (emotional support), facilitation of informed decision-making (cognitive support), and enablement of self-management including support for patient navigation of the system and coordination of care (instrumental support). While some communication behaviors maybe specific to one of the three functions (e.g., expressing empathy under emotional support), a successful two way exchange of information between patients and clinicians is central to the optimal execution of all the three functions. Thus information exchange can be conceptualized to be the communication behavior that is necessary to accomplish the three functions of PCC. Also, given that the experience of living with an illness such as cancer or other chronic illnesses like heart disease is accompanied by significant uncertainty experienced by patients at several levels, an important focus of communication across all three functions is the management of uncertainty. Thus, management of uncertainty can be conceptualized to be a sub-function of each of the three core PCC functions. Finally, fostering healing relationships can be conceptualized as an outcome of accomplishing the three core functions as manifested in patient perceptions of trust in their clinicians and health care organizations as well in their ratings of and satisfaction with care. To further refine this NCI/AHRQ formulation, and to finalize the measurement model that would drive the project, the contractor shall convene a one day face-to-face meeting at the start of the project with key scientific staff from AHRQ and NCI as well as a small group of outside experts. The contractor should budget for inviting up to 4 outside experts, to be decided by AHRQ and NCI. 3. Identify domains and sub-domains of the key constructs in the model: The contractor shall draw upon the work of RTI International and map the several domains and sub-domains identified by RTI to the various constructs outlined in the refined measurement model. 4. Get stakeholder input: The contractor shall identify a list of key stakeholders to provide input on the PCC model and associated measurable domains and sub-domains and will submit to AHRQ and NCI for approval. Once approved, the contractor shall obtain input on the model from stakeholders and the SEG. This input shall include at a minimum, validity and comprehensiveness of the constructs, whether major constructs are missing, amenability of constructs to measurement, and other areas as necessary. The contractor shall use this input as well as their own expertise to create a final model of PCC to be used for identifying concrete measures of PCC. 5. Identify clinical context for the survey. The contractor shall propose a list of potential contexts for the survey to be developed for. Considerations for the context include (at least) the phase of care, the type and/or stage of cancer, the setting of care (e.g. inpatient, outpatient, etc.). The phase of care emphasized in this project will most likely include initial diagnosis (starting from experience of symptoms or suspicion of cancer) through end of treatment. Salience of communication for accomplishing various clinical tasks or activities will be emphasized (e.g., deciding on and implementing medical tests for diagnostic or surveillance purposes, treatment decision-making and implementation, management of symptoms and side effects, etc). Ideally, we wish to identify measures that could cover a broad range of contexts, but it may be of interest also to include measures in areas that are context-specific, or may have greater validity within specific contexts. The contractor shall propose possible contexts to AHRQ and NCI for approval. 6. Identify candidate measures for the key constructs of PCC identified in the measurement model. The contractor shall use a comprehensive approach to identifying candidate measures of the key constructs in the PCC model (this would include core functions of PCC as well as associated communication-related outcomes such as trust and patient empowerment). This approach shall include at least: a. A review of the peer-reviewed and grey literature; b. A public call for measures; c. Contacting content area experts for possible measures. 7. Develop a comprehensive inventory of measures. The contractor shall summarize the measures they have found through their searching in a comprehensive database of measures, that should include at least: full specifications for the measures;known psychometric properties;what populations the measures have been validated in;any particularly relevant populations where validation is missing;and a relevant list of references. Any additional information supporting the utility of the measures for organizational-level quality monitoring as well as for population-level surveillance will be documented. 8. Identify gaps in the current measure coverage of the key constructs. Working with input from the SEG, identify major areas of the constructs that are not covered by existing measures for the clinical contexts previously agreed to. The contractor shall provide a list of important gaps with rationale to AHRQ and NCI for approval. 9. Develop new items to address gaps in measuring the constructs. The contractor shall work with AHRQ and NCI to determine what gaps outlined above should be addressed by new measures. The contractor shall then develop new items that measure constructs for which there is a gap in current measurement. Consideration will need to be given to the context, e.g. will the items cover multiple aspects of the cancer continuum or be focused on specific aspects and/or cancer types. Consideration will also need to be given for the format of the items, including response format and recall period, as well as to potential modes of administration [unreadable] paper, telephone, web, PHRs, etc. 10. Develop a list of candidate items for a final instrument to measure the key constructs. The contractor shall review the currently existing items and newly developed items, and from the available alternatives, develop a list of items recommended to be included in an instrument to measure the key constructs. The contractor shall submit to AHRQ and NCI this candidate list in an interim report, with rationale for inclusion and exclusion of candidate items, contexts anticipated that the instrument may be used in, as well as any potential barriers or challenges to use of the instrument. 11. Conduct detailed cognitive tests with a variety of patient groups. Based upon the clinical contexts selected, the contractor shall recruit patient representative of the context. They shall conduct cognitive testing of the items to assess understandability, feasibility of data collection, and validity of the items. The contractor shall obtain requisite IRB approval for this testing. While it is expected that the data collection needs for this objective may not be extensive, if any data collection protocols proposed by the contractor would require Office of Management and Budget (OMB) clearance as required by the Paperwork Reduction Act of 1995, then the contractor would be responsible for obtaining clearance with the assistance of AHRQ. Findings from the cognitive testing shall be included in the final report, and the information from this testing shall be used to modify the items and/or the overall instrument as necessary. 12. Provide final instruments based upon results of the cognitive testing. The contractor shall submit final formatted instruments, revising based upon cognitive testing, and by input of the SEG, AHRQ, and NCI. The #1 priority goal is to finalize an instrument that would include a comprehensive measurement set that can be used for assessment of patient perspectives on patient-centered communication for the purpose of quality monitoring/organizational surveillance. A secondary goal of the project is to finalize an instrument that can be used for population-level surveillance efforts. The final instruments shall be submitted to AHRQ and NCI for review and approval. 13. Provide an abbreviated instrument for a potential provider survey. The contractor shall provide an abbreviated list of items to comprise an instrument suitable for surveying providers on patient-centered communication. The instrument should include a rationale for including or excluding specific items. The instrument shall be submitted to AHRQ and NCI for review and approval. 14. Provide a draft report. The contractor shall provide a draft report describing their research project. The report should include at a minimum: an introduction describing the problems to be addressed, a detailed methods section, the results of the research projects, the conclusions from the findings, and remaining research gaps. This report could be a full report, or could consist of a series of manuscripts that provide a comprehensive description of the project. The exact form of the report shall be subject to AHRQ TOO approval. The contractor shall also identify a list of potential peer reviewers at least 4 weeks in advance of the draft due date. 15. Provide a final report. The contractor shall respond to peer and public comments (if applicable) on the report. They shall modify the report as appropriate and provide a final report and a disposition of comments to AHRQ and NCI for approval. 16. Submit a power point presentation on the project. The contractor shall prepare and submit for AHRQ and NCI approval a final power point presentation that summarizes the major objectives, methods, and findings from the project. 17. Prepare articles for publication. The contractor will work with AHRQ/NCI staff to prepare one or more articles for publication about the development and testing of the different instruments for assessing PCC. AHRQ/NCI scientific staff involved in this project will serve as co-authors as appropriate.